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Regulations and Guidance





November 27, 2018

Become Compliant with MDR as Soon as Possible

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Medical devices marketed in the European Union are required to comply with a set of medical device directives called the...

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October 25, 2017

2017 Fall AAMI Sterilization Standards Meetings Update

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The AAMI Sterilization Standards Meetings were held on 16-18 October 2017.  There were almost 300 medical device manufacturers, FDA personnel,...

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September 15, 2017

Introduction to the Validation of Sterile Medical Devices: Sterilization, Packaging, Biocompatibility, Toxicology, and Reprocessing

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For over a decade, Nelson Laboratories has been hosting educational seminars called The Science of Sterilization Validation. The aim of...

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September 6, 2017

Three-Day Webinar Series: Medical Device and Pharmaceutical Testing Regulatory Updates, Trends, and Anticipated Changes

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Learn from the industry-leading experts at Nelson Laboratories in the three-day webinar series Medical Device and Pharmaceutical Testing Regulatory Updates,...

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April 3, 2017

2017 Spring AAMI Sterilization Standards Meeting Update

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On March 20-23, 2017, I attended the Association for the Advancement of Medical Instrumentation (AAMI) semi-annual Sterilization Standards Committee Meeting....

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